Researchers from the U.S. School of Pharmacy. Montreal, demonstrate that it is not always right to extrapolate bioequivalence results from one population to another.
Purpose: During the last few years 15 years, an increasing proportion of pharmacokinetic bioequivalence studies for generic European presentations / American organizations appeared to have been held in geographical populations / ethnically distinct from those for which the drug is marketed. The results of pharmacokinetic bioequivalence studies have traditionally been considered insensitive to the population studied. However, several recent studies have suggested that this may not necessarily be true. The objective of this study was to investigate whether there were any concerns regarding the current practice of extrapolating the results of the bioequivalence study of a geographical population / ethnic to another.